Single Use Electrosurgical Knife

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Electrosurgical Knife.

Pre-market Notification Details

Device IDK171158
510k NumberK171158
Device Name:Single Use Electrosurgical Knife
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentDaphney Germain-kolawole
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-20
Decision Date2017-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170405645 K171158 000
14953170405638 K171158 000
14953170405621 K171158 000
14953170377539 K171158 000
14953170377515 K171158 000
14953170377485 K171158 000

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